Mike Bumgarner
- Role
- Sr Regulatory Affairs Specialist - Structural Heart at Medtronic
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
Experience
Sr Regulatory Affairs Specialist - Structural Heart
Dec 2020 — Present
Define regulatory strategy for transcatheter valve products Manage regulatory submission activities for new products and product maintenance for existing approved products. Team with business unit and international regulatory staffs to provide regulatory support. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare regulatory (eg, FDA) submissions for new products and product changes, as required, to ensure timely approvals for clinical studies and market release. Review labeling, promotional material, product changes and documentation for changes requiring government approval. Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams. Provide feedback and on-going support to product development teams for regulatory issues and questions.
Education
Drake University
B.A., Biochemistry, Cell & Molecular Biology
2007 — 2011
Skills
- Glp
- Gmp
- Fda
- Astm
- Laboratory Experience
- Capa
- Iso
- Nih
- Scientific Writing
- Medical Devices
- Life Sciences
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